Regulatory affairs Labelling Director
Apply NowCompany: Katalyst HealthCares and Life Sciences
Location: Cambridge, MA 02139
Description:
Responsibilities:
- Lead cross-functional labeling teams, driving alignment on strategy and content.
- Provide strategic guidance to labelling leads and serve as a liaison between the labeling team and senior leadership.
- Mentor labeling leads and review implementation plans to ensure up-to-date, compliant information is provided.
- Labelling Document Management.
- Author and manage the creation of new/revised labeling documents (TLP, CCDS, USPI, EU SmPC) with input from relevant functional areas.
- Coordinate global labeling efforts to ensure timely submission and negotiations with Health Authoritiez.
- Manage relationships with Global Regulatory Leads and escalate issues when necessary, proposing risk mitigation strategies.
- 10+ years of experience in the pharmaceutical industry, including 8+ years in labeling or 6+ years in regulatory affairs.
- Facilitate communication with cross-functional teams (clinical, safety, medical affairs, commercial) to ensure effective collaboration on labeling strategies.
- Regulatory Compliance & Precedent Analysis.
- Conduct precedent searches, analyze competitor labeling and trends, and develop competitive labeling strategies.
- Ensure alignment with global regulatory requirements and health authority expectations.
- Oversee external vendors managing labeling activities and drive continuous improvement of labeling processes.